BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 3201637 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04620
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS WITH THE SPRING TIP MISSING. A VISUAL AND TACTILE INSPECTION WAS PERFORMED WHICH IDENTIFIED THE BODY WAS FRACTURED 314.5CM FROM THE PROXIMAL END. APPROXIMATELY 15.5CM OF THE DISTAL PART OF THE WIRE IS MISSING. ALL OUTER DIAMETER MEASUREMENTS TAKEN MET SPECIFICATION. THE RETURNED DEVICE WAS SENT FOR EXTERNAL ANALYSIS ((B)(4) LAB) TO DETERMINE THE FRACTURE FAILURE MODE. THE RESULTS FOUND THAT THE SAMPLE PRESENTED EVIDENCE OF BENDING OVERLOAD EVENT IN A BRITTLE MATERIAL AS MODE OF WIRE FAILURE. NO MATERIAL ANOMALIES WERE FOUND. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY PROCEDURE, THE ROTAWIRE BROKE. THE STENOSED TARGET LESION WAS LOCATED IN THE MIDDLE AND DISTAL RIGHT CORONARY ARTERY. A 330CM ROTAWIRE FLOPPY GUIDEWIRE WAS SELECTED AND ADVANCED TO THE TARGET LESION TO GUIDE THE 1.5MM ROTABLATOR ROTALINK PLUS ROTATIONAL ATHERECTOMY SYSTEM TREAT THE TARGET LESIONS. ROTABLATION WAS PERFORMED FOR BOTH LESIONS WITHOUT DIFFICULTIES. RESISTANCE WAS NOT NOTED AT ANY MOMENT DURING THE PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR DID NOT REACH THE RADIOPAQUE MARKER IN THE DISTAL SEGMENT OF THE ROTAWIRE USED. DURING REMOVAL OF THE ROTAWIRE, IT WAS NOTED THAT THE DISTAL RADIOPAQUE MARKER STILL REMAINED IN THE THIN POSTEROLATERAL BRANCH OF THE ARTERY. UPON COMPLETE REMOVAL , IT WAS OBSERVED THAT THE ROTAWIRE BROKE. WITHIN 30 MINUTES, ATTEMPTS WERE MADE TO RETRIEVE THE BROKEN PIECE BY USING LASSO OR SNARE; HOWEVER, THE OTHER PART WAS NOT ABLE TO BE RETRIEVED. THE PROCEDURE WAS CONSIDERED DONE AS THE BLOOD FLOW WAS OBSERVED TO BE GOOD. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY PROCEDURE, THE ROTAWIRE BROKE. THE STENOSED TARGET LESION WAS LOCATED IN THE MIDDLE AND DISTAL RIGHT CORONARY ARTERY. A 330CM ROTAWIRE FLOPPY GUIDEWIRE WAS SELECTED AND ADVANCED TO THE TARGET LESION TO GUIDE THE 1.5MM ROTABLATOR ROTALINK PLUS ROTATIONAL ATHERECTOMY SYSTEM TREAT THE TARGET LESIONS. ROTABLATION WAS PERFORMED FOR BOTH LESIONS WITHOUT DIFFICULTIES. RESISTANCE WAS NOT NOTED AT ANY MOMENT DURING THE PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR DID NOT REACH THE RADIOPAQUE MARKER IN THE DISTAL SEGMENT OF THE ROTAWIRE USED. DURING REMOVAL OF THE ROTAWIRE, IT WAS NOTED THAT THE DISTAL RADIOPAQUE MARKER STILL REMAINED IN THE THIN POSTEROLATERAL BRANCH OF THE ARTERY. UPON COMPLETE REMOVAL , IT WAS OBSERVED THAT THE ROTAWIRE BROKE. WITHIN 30 MINUTES, ATTEMPTS WERE MADE TO RETRIEVE THE BROKEN PIECE BY USING LASSO OR SNARE; HOWEVER, THE OTHER PART WAS NOT ABLE TO BE RETRIEVED. THE PROCEDURE WAS CONSIDERED DONE AS THE BLOOD FLOW WAS OBSERVED TO BE GOOD. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY PROCEDURE, THE ROTAWIRE BROKE. THE STENOSED TARGET LESION WAS LOCATED IN THE MIDDLE AND DISTAL RIGHT CORONARY ARTERY. A 330CM ROTAWIRE FLOPPY GUIDEWIRE WAS SELECTED AND ADVANCED TO THE TARGET LESION TO GUIDE THE 1.5MM ROTABLATOR ROTALINK PLUS ROTATIONAL ATHERECTOMY SYSTEM TREAT THE TARGET LESIONS. ROTABLATION WAS PERFORMED FOR BOTH LESIONS WITHOUT DIFFICULTIES. RESISTANCE WAS NOT NOTED AT ANY MOMENT DURING THE PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BURR DID NOT REACH THE RADIOPAQUE MARKER IN THE DISTAL SEGMENT OF THE ROTAWIRE USED. DURING REMOVAL OF THE ROTAWIRE, IT WAS NOTED THAT THE DISTAL RADIOPAQUE MARKER STILL REMAINED IN THE THIN POSTEROLATERAL BRANCH OF THE ARTERY. UPON COMPLETE REMOVAL , IT WAS OBSERVED THAT THE ROTAWIRE BROKE. WITHIN 30 MINUTES, ATTEMPTS WERE MADE TO RETRIEVE THE BROKEN PIECE BY USING LASSO OR SNARE; HOWEVER, THE OTHER PART WAS NOT ABLE TO BE RETRIEVED. THE PROCEDURE WAS CONSIDERED DONE AS THE BLOOD FLOW WAS OBSERVED TO BE GOOD. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301649 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) H802228240020 15648988

    Patients

    Seq Age Sex Outcome Treatment
    1 Other